accu-beads® - accu-beads® are intended for use as a quality - HAMILTON THORNE, INC.

Duns Number:152161337

Device Description: accu-beads® are intended for use as a quality control material to assist in verifying the accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and automated sperm concentration measurements.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

accu-beads®

Version/Model Number

accu-beads®

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NRF

Product Code Name

Material, Quality Control, Semen Analysis

Device Record Status

Public Device Record Key

08aa9145-b80f-42c5-913f-d379b2f978f1

Public Version Date

April 07, 2022

Public Version Number

1

DI Record Publish Date

March 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAMILTON THORNE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53